Biologic therapeutics are well known and widely prescribed due to their unmatched benefits and efficacy. However, such biologic therapeutics may be associated with undesired side effects at high systemic concentrations. Additionally, repeated painful and expensive administration of biologics may be required, decreasing certain benefits and appeal to patients and providers. It is therefore desirable to provide controlled, sustained release formulations for biologic therapeutic delivery to reduce systemic exposure and frequency of administration, as well as to improve biologic therapeutic safety and patient compliance.
Osteoarthritis is one example of a pathology with a significant unmet need for controlled release biologic therapeutics. Over 38 million people are currently affected by osteoarthritis in the United States alone. Osteoarthritis is a progressive ailment characterized by joint pain, stiffness and limited range of motion, and typically affects joints of the hands, spine, hip and knee. There currently are no FDA approved drugs for disease modification in osteoarthritis. Currently, osteoarthritis pain is managed by NSAIDs and opioids. Similarly, treatment of macular degeneration, which progressively impairs vision and leads to blindness, is hampered by the necessity of repeated injections into the eye. Controlled release formulations of biologic therapeutics providing low systemic exposure, low maximum local and systemic concentrations, less frequent dosing requirements, higher effective dosing and improved compliance, such as those disclosed herein, represent a significant breakthrough in treatment of osteoarthritis, macular degeneration, and other ailments.